Clinical Study on the Prevention and Treatment of Postoperative Gastrointestinal Dysfunction by Acupuncture Under ERAS Management Based on Artificial Intelligence Monitoring

NCT07335237 | Completed Phase 2 DMC

• 1 other identifier: 2022NL-KS100
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Acupuncture for Faster Recovery After Colorectal Surgery

1. 1.What is this study about? Colorectal cancer is a common health condition that usually requires surgery. While surgery is effective, it often leads to a temporary "shutdown" of the digestive system, known as Postoperative Gastrointestinal Dysfunction (POGD). Patients may experience bloating, nausea, vomiting, and a delay in passing gas or having bowel movements. This study explores whether acupuncture can help the gut "wake up" faster and improve overall recovery.
2. 2.Why is this research important? Currently, hospitals use a modern management system called ERAS (Enhanced Recovery After Surgery) to help patients recover. However, many patients still suffer from gut-related discomfort. We want to see if combining traditional Chinese medicine (acupuncture) with modern ERAS protocols provides a better, faster, and more comfortable recovery than ERAS alone.
3. 3.What will happen during the study? Patients participating in this study at the affiliated hospital of Nanjing University of Chinese Medicine are randomly assigned to one of two groups:
4. 4.What are the potential benefits? Based on our research findings involving 70 clinical cases, patients who received acupuncture experienced:
5. 5.Is it safe? Acupuncture is a safe, drug-free, and minimally invasive therapy. It works by stimulating the vagus nerve and balancing the body's internal systems. Combined with the precision of AI monitoring, this approach ensures that the recovery process is both natural and scientifically tracked.
6. 6.Conclusion The goal of this study is to provide a "green" and effective solution to help colorectal cancer patients suffer less after surgery and return to their normal lives as quickly as possible.

Conditions

Colectomy Left/Right/Total Under Laparotomy; Cancer; Accupuncture; Heart Rate; Colectomy; Chinese Medicine

Keywords

Colectal Cancer; Chinese Medicine; Accupuncture

Outcome Measures

Primary Outcomes (1)

• Time to first postoperative flatus

  This measure records the duration (in hours) from the completion of the surgical procedure (end of skin closure) to the patient's first reported passage of flatus. It serves as a key clinical indicator of the recovery of intestinal motility and the resolution of postoperative ileus.

  From the end of surgery until the first passage of flatus, typically expected within 72 to 120 hours post-surgery.

Secondary Outcomes (1)

• Time to first postoperative defecation

  From the end of the surgery until the 7th day after the operation (or until the patient is discharged from the hospital).

Study Arms (1)

Standard ERAS Management

ACTIVE COMPARATOR

Patients in this arm receive standard perioperative care following the established Enhanced Recovery After Surgery (ERAS) protocols, including early mobilization and early oral feeding, without acupuncture intervention.

Other: Accupuncture

Interventions

Accupuncture OTHER

Specific Synergistic Acupoint Selection: The protocol uses a specialized combination of four acupoints-Zusanli (ST36), Neiguan (PC6), Tianshu (ST25), and Taichong (LR3). This specific "cluster" is designed not just for gut motility, but to specifically target the "Brain-Gut Axis" to reduce the systemic inflammatory response and postoperative pain simultaneously. High-Frequency Perioperative Timing: The intervention begins within 12 hours post-surgery, which is earlier than many traditional protocols. It is administered with a high-frequency density (every 12 hours for the first 72 hours), ensuring a consistent "dose" of neuro-stimulation during the most critical window of gastrointestinal paralysis.

Standard ERAS Management

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 80 years, male or female.
• Diagnosed with colorectal malignancy by pathology or cytology.
• Scheduled for elective radical resection of colorectal cancer (laparoscopic or open surgery).
• ASA physical status classification: I-III.
• Willing and able to provide written informed consent.

You may not qualify if:

• Patients with severe primary diseases of the heart, brain, kidney, hematopoietic, or endocrine systems.
• History of major abdominal surgery or intestinal obstruction that significantly alters bowel anatomy.
• Emergency surgery cases (e.g., acute obstruction, perforation, or peritonitis).
• Contraindications to acupuncture (e.g., local skin infection, scars, or severe coagulation disorders).
• Currently participating in other clinical trials.

Sponsors & Collaborators

• Jiangsu Province Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Affliated Hospital of Nanjing Universitty of Chinese Medicine

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: September 1, 2022
• Primary Completion: March 28, 2025
• Study Completion: May 28, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (1)